Engagement in CHildhood-Onset Systemic Lupus

NCT ID: NCT05693571

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2027-02-28

Brief Summary

The goal of this observational (Aim 1) and pilot study (Aim 2) is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions the overall study attempts to answer are:

1. Whether anhedonia (a core symptom of depression) predicts disengagement in care

2. Whether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus.

Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.

Detailed Description

This registration is exclusive to the pilot study (Protocol Aim 2). The primary objective of Aim 2 is to assess the feasibility and acceptability of an adapted Valera application (app) in adolescents and young adults (AYA) with childhood-onset systemic lupus erythematosus (cSLE). As a part of Aim 1 (not a component of this registration), using a recognized patient-engaged methodology, "ADAPT-ITT"22, the study team will iteratively adapt and test the content and utilities of the app for cSLE AYA. During the 6-month pilot study which constitutes Aim 2, the investigator team will examine feasibility and acceptability through mixed-methods. Feasibility and acceptability will be assessed via app use and validated feasibility and acceptability of intervention measures.

Conditions

Lupus Erythematosus, Systemic; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Valera Pilot Study

All participants in the open-label pilot study will be provided with the Valera smart phone application and online care manager dashboard

Group Type: EXPERIMENTAL

Valera Smart Phone Application and Care Manager Dashboard

Intervention Type: BEHAVIORAL

Valera mobile health application will provide educational materials around mental health and Systemic Lupus Erythematosus (SLE) and the ability to connect to a SLE care team via a care manager.

Interventions

Valera Smart Phone Application and Care Manager Dashboard

Valera mobile health application will provide educational materials around mental health and Systemic Lupus Erythematosus (SLE) and the ability to connect to a SLE care team via a care manager.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants 15-25 years old meeting American College of Rheumatology (ACR) Revised SLE Classification Criteria and/or European League Against Rheumatism/ACR Classification Criteria and/or 2012 SLE International Collaborating Clinic Criteria and followed at the Children's Hospital at Montefiore.
• Must be diagnosed with SLE before 19 years of age (based on Childhood-onset systemic lupus erythematosus (cSLE) definition)

Exclusion Criteria

• Non-Spanish or non-English speaking
• Participants anticipating transitioning to an outside rheumatologist for lupus care within the period of study follow-up
• Current psychotic disorders. However, attention-deficit/hyperactivity disorder, anxiety disorders, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, and substance abuse disorders are not uncommon among adolescents and young adults (AYA) and will be allowed. Suicidal ideations (SI) and self-injurious acts (cutting) are common in depression and will be allowed (defined as passive SI).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Childhood Arthritis and Rheumatology Research Alliance

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamar Rubinstein, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

K23AR080803

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-14314

Identifier Type: -

Identifier Source: org_study_id